Boston Scientific (NYSE:BSX) has prevailed in dismissing a whistleblower suit alleging its sales of the Cognis cardiac resynchronization therapy defibrillators and Teligen implantable cardioverter defibrillators between 2008 and 2009 violated various false claims acts, according to court documents released late last week.
In the suit, Boston Scientific was accused of defrauding the FDA by not reporting alleged defects in the devices which caused insecure connections between the leads and headers they attached to.
The complaint alleged that Boston Scientific was made aware of the issue after launching the devices in Europe, and upon US launch it engaged in a strategy of minimizing medical device reports to the FDA covering the defects.
When the company released revised versions of the devices, it called the revisions modifications and not corrections, according to the complaint. Boston Scientific then issued a recall for the original devices in mid 2009.
The United States District Court for the District of Minnesota dismissed the allegations, referencing that while allegations were made that the company defrauded the FDA and violated the False Claims Act, there were no specific references to actions or statements taken to defraud the Agency.
“To satisfy the rule, “the complaint must plead such facts as the time, place, and content of the defendant’s false representations, as well as the details of the defendant’s fraudulent acts, including when the acts occurred, who engaged in them, and what was obtained as a result,” Judge Joan Ericksen wrote, according to court documents.
The complaint was dismissed without prejudice, leaving open the opportunity for the complaint to be amended, according to court documents.